Indications
For temporary relief of external itching and soreness in the urogenital region.
Pleo Nig
FDA Label NDC 60681-2103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Nig (NDC 60681-2103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications, ingredients, inactive ingredients, tamper evident, dosage, warning, principal display panel - 20 capsules carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
1 capsule contains 330 mg Aspergillus niger 4X.
Inactive Ingredients
Lactose, Capsule shells consist of Hypromellose (HPMC).
Tamper Evident
Do not use this product, if imprinted inner blister pack is broken or if imprinted security strip on carton is torn.
Dosage
1–3 capsules daily, either before breakfast or at bedtime.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking this product.
Principal Display Panel - 20 Capsules Carton
Pleo™ Nig
CAPSULES 4X
Homeopathic
Antipruritic Medicine
Indications: For temporary
relief of external itching
and soreness in the
urogenital region.
ORIGINAL ENDERLEIN
20 CAPSULES
Principal Display Panel (20 Capsules Carton)
* Please review the disclaimer below.
